What are the responsibilities and job description for the Clinical Research Associate position at Melodi Health?
Company Description
Melodi Health offers novel technologies that improve patient outcomes for women undergoing breast surgery.
Melodi Health manufactures the Melodi Matrix, designed to support soft tissue space around a prosthetic device while delivering antibiotics to surrounding tissue. The Melodi Matrix is currently an investigational device being studied in a prospective, multi-center, randomized, controlled clinical trial in breast reconstruction.
Role Description
This is a full-time role based in Minneapolis, MN, allowing for a combination of on-site work and remote opportunities. As a Clinical Research Associate, you will be responsible for supporting the planning, execution, and oversight of clinical trials to ensure they are conducted in accordance with the study protocol, regulatory requirements, and company standards. This role requires strong attention to detail, excellent communication skills, and the ability to build and maintain effective relationships with clinical sites and internal stakeholders.
Key Duties & Responsibilities
- Display a confident and thorough understanding of study protocol(s), the investigational device, and relevant disease state information.
- Perform all types of monitoring activities-both onsite and remote-with a high level of attention to quality and attention to detail.
- Conduct clinical site visits from site qualification through end of study.
- Participate in site selection, including collection of required documentation.
- Conduct source document verification.
- Assist with development, review and updating of case report forms.
- Ensure patient safety is maintained at all times and verify informed consent procedures are followed.
- Provide timely and high quality documentation of all monitoring and site related activities including monitoring reports.
- Build, foster and maintain strong working relationships with the clinical site staff and investigators.
- Assist during company audits, clinical site audits and inspections by regulatory authorities.
Qualifications
- Bachelor’s degree in a life sciences or health-related field required
- Prior experience in clinical research or monitoring
- Knowledge of GCP, ICH guidelines, and applicable regulatory requirements
- Strong organization, analytical, and interpersonal skills.
- Ability to travel as required.